Edaravone medicine composition and preparation method thereof

A technology of edaravone and composition, applied in the directions of drug combination, pharmaceutical formulation, drug delivery, etc., can solve the problem of not selecting antioxidants, etc., and achieve the effects of good drug efficacy and good stability

Active Publication Date: 2016-06-01
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the water injection of the edaravone pharmaceutical composition is in an acidic environment, and thiobisethyl alcohol is unstable in an acidic environment, so it is not an ideal antioxidant choice

Method used

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  • Edaravone medicine composition and preparation method thereof
  • Edaravone medicine composition and preparation method thereof
  • Edaravone medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] prescription:

[0049]

[0050]

[0051] Preparation Process:

[0052] (1) Under the condition of nitrogen protection, take the prescribed amount of propylene glycol and 70% to 80% of the prescribed amount of water for injection to stir and mix, heat to 60°C, and the residual oxygen content in the liquid is lower than 2ppm;

[0053] (2) Under the condition of nitrogen protection, another prescribed amount of tea polyphenols and vitamin C was added and fully dissolved with water for injection;

[0054] (3) Under the condition of nitrogen protection, slowly add the tea polyphenols and vitamin C aqueous solution of step (2) into the mixed solution of propylene glycol and water in step (1), and add the prescribed amount of Eda with an average particle diameter of 20 μm at the same time Lavone, stir well until completely dissolved;

[0055] (4) Under nitrogen protection conditions, add 0.1% active carbon for needles to the mixed solution in step (3) and stir evenly, an...

Embodiment 2

[0060] prescription:

[0061]

[0062] Preparation Process:

[0063] (1) Under nitrogen protection conditions, take the prescribed amount of propylene glycol and 70% to 80% of the prescribed amount of water for injection to stir and mix, heat to 75°C, and the residual oxygen content in the liquid is lower than 2ppm;

[0064] (2) Under the condition of nitrogen protection, another prescribed amount of tea polyphenols and vitamin C was added and fully dissolved with water for injection;

[0065] (3) Under the condition of nitrogen protection, slowly add the tea polyphenols and vitamin C aqueous solution of step (2) into the mixed solution of propylene glycol and water in step (1), and add the prescribed amount of Ida with an average particle diameter of 5 μm at the same time Lavone, stir well until completely dissolved;

[0066] (4) Under nitrogen protection conditions, add 0.2% active carbon for needles to the mixed solution in step (3) and stir evenly, and filter the char...

Embodiment 3

[0071] prescription:

[0072]

[0073] Preparation Process:

[0074] (1) Under the condition of nitrogen protection, take the prescribed amount of propylene glycol and 70% to 80% of the prescribed amount of water for injection to stir and mix, heat to 80°C, and the residual oxygen content in the liquid is lower than 2ppm;

[0075] (2) Under the condition of nitrogen protection, another prescribed amount of tea polyphenols and vitamin C was added and fully dissolved with water for injection;

[0076] (3) Under the condition of nitrogen protection, slowly add the tea polyphenols and vitamin C aqueous solution of step (2) into the mixed solution of propylene glycol and water in step (1), and add the prescribed amount of Ida with an average particle diameter of 10 μm at the same time Lavone, stir well until completely dissolved;

[0077] (4) Under nitrogen protection conditions, add 0.3% activated carbon for needles to the mixed solution in step (3) and stir evenly, and filte...

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Abstract

The invention belongs to the technical field of medicine and specifically relates to an edaravone medicine composition. The medicine composition is a hydro-acupuncture agent for injection and comprises 1.5 mg / mL of edaravone, 0.5-1.0 mg / mL of tea polyphenol, 1.0-2.0 mg / mL of vitamin C and 0.07-0.2 mg / mL of propylene glycol. According to the medicine composition, the edaravone and the tea polyphenol achieve a synergistic effect, the capacity of removing free radicals of the edaravone is enhanced, the function of protecting cranial nerves is improved, and meanwhile good stability is achieved.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a pharmaceutical composition of Edaravone. Background technique [0002] Edaravone is one of pyrazolone derivatives, its chemical name is 3-methyl-1-phenyl-2-pyrazolin-5-one, and its molecule is C 10 h 10 N 2 O, the structural formula is as follows: [0003] [0004] It was first developed by Japan's Mitsubishi Tokyo Pharmaceutical Company, and was approved for clinical use by the Ministry of Medical Labor and Welfare in Japan in April 2001. The trade name is Radicut. The drug is listed in Japan in the form of water injection, the specification is 20mL: 30mg, the excipients are sodium bisulfite and cysteine ​​hydrochloride, the usual dosage is 20mg twice a day, dissolved in normal saline or other diluents for intravenous drip Note, generally no more than 14 days of continuous use. [0005] Edaravone is a brain protectant (free radical scavenger). Clinical studies sugge...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4152A61K47/22A61P9/10A61P25/00A61P39/06
CPCA61K9/0019A61K9/08A61K31/4152A61K47/22
Inventor 钟正明
Owner HAINAN HERUI PHARMA
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